Training: IVDR Impact on Clinical Trials Assays and Companion Diagnostic Development

Speakers: Véronique Treil, Pharm D and Silvia Anghel, PhD
Duration: 2 hours
Date: October 7th 2025, Online
9:00 AM – 11:00 PM US Eastern Daylight Time (EDT)
3:00 PM – 5:00 PM Central European Summer Time (CEST)

• Training Objectives

  This training will help you to understand how to manage IVDR and CTR compliance of assays used in clinical trial studies in Europe, clarifies pharmaceutical sponsor and device manufacturer’s responsibilities for regulatory compliance to IVDR, and identify IVDR requirements for Companion Diagnostics clinical evaluations and conformity assessment.

• Training Content

  • Provide an overview of the 2017/746 EC Regulation (IVDR) and the qualification of assays as In Vitro Diagnostic devices (IVD) and specifically as Companion Diagnostics (CDx) devices.
  • Define the impact of the full implementation of CTR (2014/536) on assays used in drug clinical trials and responsibilities of the different stakeholders in ensuring compliance
  • Understand the different types of Clinical Trial Assays, and the key elements to ensure regulatory compliance to IVDR and CTR.
  • Review the specific requirements for the conformity assessment of Companion Diagnostics under IVDR
  • Define approaches for an efficient clinical evidence strategy for Companion Diagnostics

• Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment

• Target Audience

  • Executive management
  • Assay development scientists and IVD product managers
  • Pharmaceutical Clinical Affairs and Regulatory Affairs personnel in charge of developing a clinical strategy involving companion diagnostic, designing the clinical trial studies and ensuring regulatory compliance.
  • IVD device manufacturer Clinical Affairs and Regulatory Affairs personnel in charge of developing a clinical strategy involving companion diagnostic, designing the clinical performance studies and ensuring regulatory compliance.

• Price

  EUR 215, including course material and certificate